PO SUM ON HEALING BALM

Product NDC
54155-053
11-digit product format
541550053
Labeler code
54155
Product ID
54155-053_5d2fca8b-d9c2-5405-e063-6394a90a78c5
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
OINTMENT
Route
TOPICAL
Labeler
PO SUM ON MEDICINE FACTORY LIMITED
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-27
Marketing end
2030-09-02
Substance
MENTHOL
Active strength
13 g/100g
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
PO SUM ON HEALING BALM

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL13 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54155-053-01PO SUM ON HEALING BALM1 in 1 PACKETOINTMENT14
54155-053-01PO SUM ON HEALING BALM3.5 g in 1 JAROINTMENT3.54
54155-053-02PO SUM ON HEALING BALM18 g in 1 JAROINTMENT184
54155-053-02PO SUM ON HEALING BALM1 in 1 BOXOINTMENT14
54155-053-03PO SUM ON HEALING BALM10 g in 1 JAROINTMENT104
54155-053-03PO SUM ON HEALING BALM1 in 1 BOXOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54155-053PO SUM ON HEALING BALM (MENTHOL) OINTMENT [PO SUM ON MEDICINE FACTORY LIMITED]3Current NDC, Legacy NDC, 6 package rows20241127_0c89bfec-48b9-4d48-9e03-f9324447de0c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 75 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coralite Capsaicin Heat Patch 2ctCAPSAICINUnited Exchange Corp.4128b1ac-f540-2611-e063-6294a90ac98b2025-10-08WarningsExact identifier
application number: M017
Ombre Men overtime wipesBENZOCAINESambria Pharmaceuticals, LLC405f23ca-99c1-4db4-aba1-2fd7f93f55ee2025-10-07WarningsExact identifier
application number: M017
Pain free IVLIDOCAINESambria Pharmaceuticals, LLC7aa4cb20-d452-417f-afdb-307df754ed752025-10-07WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONECVS PHARMACY, INCb3bdff5e-37fe-442a-a370-7b19799ea7812025-10-07WarningsExact identifier
application number: M017
HealthWise Pain Relief PatchMENTHOL, METHYL SALICYLATEVeridian Healthcareb65932fd-ee9f-4fa2-b842-01e0f54133c92025-10-07WarningsExact identifier
application number: M017
AREX SINSIN PASCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.2013ea44-e2ea-4b36-bddb-7f64163284b62025-10-07WarningsExact identifier
application number: M017
SINSINPAS LIDOCAINE PAIN RELIEVINGLIDOCAINESinsin Pharmaceutical Co., Ltd.82c0a036-8750-5b3d-e053-2a91aa0a18152025-10-07WarningsExact identifier
application number: M017
SINSIN MULPASL-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR, CHLORPHENIRAMINE MALEATE, THYMOLSinsin Pharmaceutical Co., Ltd.81baffcb-c08e-4616-e053-2a91aa0aaf152025-10-07WarningsExact identifier
application number: M017
Arex Sinsin PasCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.a851854a-5dfe-4bd5-95f6-67c3f13f11872025-10-07WarningsExact identifier
application number: M017
Sinsinpas Arex Flex Gel Pain Relieving PatchL-MENTHOLSinsin Pharmaceutical Co., Ltd.1758ef9b-4fac-4066-e063-6394a90a8cc32025-10-07WarningsExact identifier
application number: M017
SINSINPAS CORN REMOVERSALICYLIC ACIDSinsin Pharmaceutical Co., Ltd.e2771dfc-ee57-553f-e053-2a95a90af2812025-10-07WarningsExact identifier
application number: M017
Feminine Anti-Itch CremeBENZOCAINE, RESORCINOLQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)aa6cc963-dc60-5222-e053-2995a90acaf62025-10-06WarningsExact identifier
application number: M017
TheraCare 2% Diphenhydramine Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEVeridian Healthcare5999b677-63dd-49c6-b5b8-7b3c117ecc5c2025-10-06WarningsExact identifier
application number: M017
HealthWise Pain ReliefMENTHOLVeridian Healthcare06be5331-7a1e-4ab3-9f17-2d350bd4b8902025-10-02WarningsExact identifier
application number: M017
equate Burn ReliefLIDOCAINE HYDROCHLORIDEWalmart Inca90cbd92-80a5-4463-8152-b83165121a6f2025-10-02WarningsExact identifier
application number: M017
AsperFlex HOTCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.a6cb0656-8866-44ff-b40c-73655ff687212025-10-02WarningsExact identifier
application number: M017
AsperFlex Original Maximum StrengthMENTHOLAkron Pharma Inc.d766c61e-c48b-4aff-97b0-678159479e032025-10-02WarningsExact identifier
application number: M017
HealthWise Feminine Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare1f9110da-f448-8e20-e063-6294a90a42752025-10-02WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCdc704403-e2aa-47f7-a7f4-f6afe1547ca82025-10-01WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCe02558a9-fe2b-4f28-9fd3-7308f859d7592025-10-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923499menthol 13 % Topical OintmentPSN0c89bfec-48b9-4d48-9e03-f9324447de0c4
1923499menthol 0.13 MG/MG Topical OintmentSCD0c89bfec-48b9-4d48-9e03-f9324447de0c4
1923499menthol 13 % Topical OintmentSY0c89bfec-48b9-4d48-9e03-f9324447de0c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54155-053-01541550053011 JAR in 1 PACKET (54155-053-01) / 3.5 g in 1 JAR1 jar2026-08-272030-09-02NoNoCurrent
54155-053-02541550053021 JAR in 1 BOX (54155-053-02) / 18 g in 1 JAR1 jar2026-08-272030-09-02NoNoCurrent
54155-053-03541550053031 JAR in 1 BOX (54155-053-03) / 10 g in 1 JAR1 jar2026-08-272030-09-02NoNoCurrent